Montana Legislation: Drugs Can Be Sold After Phase 1 Without FDA Approval

Montana has passed a bill allowing medical institutions to sell unapproved treatments. Under this legislation, doctors can apply for licenses to open experimental treatment clinics and recommend or sell therapies that have not been approved by the U.S. FDA. Once signed by the governor, the law would become the most permissive in the U.S. for using drugs that have not undergone full testing.

Stephanie Arnett/MIT Technology Review | Adobe Stock

The bill permits all drugs manufactured within the state to be sold in-state, as long as they have completed Phase 1 clinical trials—the initial human testing phase, typically small in scale, aimed at proving a new therapy is not harmful, but not designed to verify efficacy.

This means therapies that have completed Phase 1 trials may immediately be sold within the state without FDA approval. If a treatment enters Phase 2 but faces funding challenges, it can be commercially applied to Montana residents directly.

The only restriction is that all treatments must be manufactured within Montana.

This has potentially revolutionary implications for cell and gene therapy. The new policy returns choice to patients—anyone willing to assume the risk may travel to Montana to access potentially life-saving or life-extending innovative treatments.

The bill passed the state legislature on April 25 and is expected to be signed by the governor. It essentially expands Montana’s existing “Right to Try” law, which was initially designed to allow terminally ill patients access to experimental drugs. The new law was drafted and lobbied for by a group of longevity enthusiasts, including scientists, libertarians, and influencers.

These advocates hope Montana can become a testing ground for experimental drug access. Todd White, head of an anti-aging research organization and a contributor to the bill, said federal-level actions could further promote Right to Try laws, stating, “I see no reason other states won’t follow suit.”

Supporters believe the bill affirms bodily autonomy, as “any attempt to restore medical autonomy deserves praise.” They hope the new law enables people to try unproven drugs that might extend life without going abroad, potentially turning Montana into a medical tourism hub.

However, ethicists and legal scholars are skeptical. Alison Bateman-House, a bioethicist at NYU, and others expressed concern over the ethical risks and potential harm of selling unverified treatments.

Accessible Innovation?

There are currently no approved drugs to treat human aging. Some in the longevity field believe regulation hinders such drug development. U.S. law requires proof of safety and efficacy before a drug can be marketed—a rule dating back to the 1960s after the thalidomide tragedy involving birth defects.

Normally, drugs must undergo several trial phases: Phase 1 with 20–100 healthy volunteers for safety testing; Phase 2 and 3 with hundreds to thousands of patients to evaluate dosage and efficacy; and post-approval monitoring for side effects. This process can take more than a decade—especially frustrating for those anxious about aging.

The existing Right to Try law carved out exceptions for terminal patients to access drugs that had passed Phase 1 but not received FDA approval. Montana passed its first Right to Try law in 2015; a federal version followed around 2018. In 2023, Montana expanded it to cover all patients, not just those terminally ill, allowing any resident to use drugs that had completed Phase 1. This expansion was celebrated by longevity enthusiasts, some of whom had lobbied for it.

However, its implementation fell short due to lack of licensing, procedures, and clinic registration regulations—issues the new bill aims to fix by defining the regulatory framework for service providers.

“The bill solves the problem of how clinics can legally operate in Montana,” said Dylan Livingston, founder of the lobbying group Longevity Initiative Alliance.

He noted that many Americans currently travel abroad for illegal experimental treatments, such as costly and unverified stem cell and gene therapies. “If you must try experimental gene therapy, why not stay in the U.S.?” he said, pointing out that a new drug to clear senescent cells is about to begin a Phase 2 trial for diabetic eye disease, which could retain capital and offer better medical conditions domestically.

A “Freeport” for Longevity

The “Global Alliance for Regenerative Medicine” clinic on Roatán Island, Honduras, charges $20,000 for controversial anti-aging gene therapies, serving clients including longevity influencer Bryan Johnson.

Tech entrepreneur Niklas Anzinger established “Zion City” in a Honduran special economic zone, where residents co-create healthcare regulations. This is his second attempt at a “l(fā)ongevity research haven” where biotech firms can rapidly develop anti-aging therapies and individuals can freely access experimental treatment. (His first community, Vitalia, with its biohacking lab, ended due to founder disagreements.)

“Right to Try was once the last hope for terminal patients. Now, it's a way to gain early access to treatment,” said White. The new bill mainly builds infrastructure for selling experimental therapies—for example, requiring clinics to hold annually renewed licenses and shielding prescribing doctors from disciplinary action.

The bill also imposes stricter informed consent requirements than the current Right to Try laws. Before using experimental drugs, patients must sign a written consent form listing approved alternatives and potential worst-case outcomes.

Safety Boundaries

Despite enhanced informed consent and Phase 1 testing requirements, Livingston admits he personally wouldn’t try experimental therapies: “I’d rather be the 50 millionth person to get gene therapy.”

Experts warn of the risks to “adventurous” patients: Phase 1 trials usually involve fewer than 50 healthy participants—too small to detect side effects occurring in 5% of cases or complex drug interactions. Around 90% of clinical trial drugs fail, with 17% halted in later stages due to safety. Even approved drugs can be withdrawn due to rare, serious side effects—23 cancer drugs with accelerated approval were withdrawn between 1992–2023; 95 drugs were pulled between 1950–2013 for fatal risks.

Sharona Hoffman, a law professor at Case Western Reserve University, said the idea of making drugs available post-Phase 1 is troubling. Doctors’ primary duty is to do no harm—“how can we ensure safety without full testing?”

Supporters argue people should be free to decide their own risk tolerance, criticizing existing regulation as an infringement on bodily rights and medical freedom. Opponents say personal freedom ends when it poses public risks—like drunk driving.

Legal scholars note that past court cases opposing FDA restrictions failed: in 2003, the Abigail Alliance sued the FDA to let terminal cancer patients access post-Phase 1 experimental drugs. The court rejected the claim in 2007.

Bateman-House also questioned the bill’s requirement that experimental treatment centers allocate 2% of annual net profits to support access for Montana residents. While intended to promote equity, she warned it might pose added risks to the community and be “pseudo-scientific fairness.” Charging for unproven treatments is unethical when efficacy is unknown. “The U.S. system is built on evidence of safety and efficacy—no evidence, no benefit.”

Montana clinics can only sell drugs produced in-state; federal law requires FDA approval for interstate drug sales. White dismissed concerns, citing the presence of major manufacturers like Pfizer in Montana: “That’s part of why we picked the state.” He believes the current administration supports reforming federal drug production laws. (FDA official Marty Makary has repeatedly criticized the agency’s approval pace.)

Livingston said several clinics are planning to open under the new law: “Six have expressed interest, two to three are confirmed.” Minicircle, the biotech company developing a controversial anti-aging gene therapy based on follistatin, told MIT Technology Review they are “considering” entry.

“This is a great opportunity for Montana—and the U.S.—to capture the medical tourism market. No other place in the world has such a relaxed regulatory environment,” he said.